Cleared Traditional

Howell Biliary Aspiration Needle (K153763) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153763 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Apr 2017
Decision
463d
Days
Class 2
Risk

K153763 is an FDA 510(k) clearance for the Howell Biliary Aspiration Needle. Classified as Instrument, Biopsy, Suction (product code FCK), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 6, 2017 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K153763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2015
Decision Date April 06, 2017
Days to Decision 463 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 130d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCK Instrument, Biopsy, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCK Instrument, Biopsy, Suction

Devices cleared under the same product code (FCK) and FDA review panel - the closest regulatory comparables to K153763.
MULTIPLE BIOPSY SYSTEM
K103326 · United States Endoscopy Group, Inc. · Apr 2011
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
K061201 · United States Endoscopy Group, Inc. · May 2006
DSNARE, MODEL 00711087
K051637 · United States Endoscopy Group, Inc. · Oct 2005
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · United States Endoscopy Group, Inc. · Oct 1995
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K895900 · Wilson-Cook Medical, Inc. · Jan 1990